A potential customer is looking for a "proof of concept" design from my company. I was just asked by a salesperson here if we needed to do all the activities involved with design and the quality system (input, output, review, verification, etc.). This would be a class 2 medical device.

I told him I didn't deem it necessary to envoke all the bells and whistles for a proof of concept design. I did say however that this documentation/records should be in place if it goes into production.

Was I right, wrong, or is it a "it depends"? Anybody ever have a similar situation?

In my world "proof of concept" is a prototype.

This is part of the design process, not a design process in and of itself.

So if I have a customer asking for proof of concept then I'm going to charge them for that, document everything, and make sure I have recourse if they take the "proof of concept" to another supplier and say "can you make this cheaper?".

We've struggled with this before, too. I agree with ScottK's assessment that it would be a prototype. Where we've run into trouble is that the customer eventually considered it a product they could use to perform clinical trials. So now if we are asked to do such proofs, we either make sure the above couldn't happen or show the customer the benefits of complying with all the design controls in the first place.

And I certainly agree with ScottK's recommendation to protect yourself against a client taking your groundwork and then putting the rest out for bid.

And I certainly agree with ScottK's recommendation to protect yourself against a client taking your groundwork and then putting the rest out for bid.

Frito Lay did that with a former company I worked for.
But I think it was legal in that they paid for the design services and prototyping.
I left the company before it was finalized but I did all the leg work on QA end before I left.
About a year later I saw the product on the shelf - and not molded by my former employer.